FDA Inspection
Ortho Prime Direct IncOrtho Prime Direct Inc – FDA Inspection, Dec 12, 2011
Record Details
This FDA Inspection record concerns Ortho Prime Direct Inc, with an inspection on December 12, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ortho Prime Direct Inc
- Inspection Date
- December 12, 2011
- Product Type
- Devices
View Company Profile
ID · f217db50-ac8e-456b-bed0-6d130d0693e9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 755755
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 820.198(a)Complaints
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.200(d)Service reports
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 803.17Lack of Written MDR Procedures
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